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Development of an Innovative Berberine Food-Grade Formulation with an Ameliorated Absorption: In Vitro Evidence Confirmed by Healthy Human Volunteers Pharmacokinetic Study

Petrangolini G, Corti F, Ronchi M, Arnoldi L, Allegrini P, Riva A
Evidence-based complementary and alternative medicine : eCAM 2021 2021:7563889

Bibliography

PubMed
PMID 34904017
PubMed Central
PMC8665891
Funding
Funding was not established from the accessible source; this is not a declaration of no funding.
Competing interests
All authors were employees of Indena, the formulation developer.

Study snapshot

DesignHealthy-volunteer formulation pharmacokinetic study
ModelHuman participants; see population
Sample12 healthy volunteers
InterventionBerberine chloride 500 mg (452 mg berberine) versus Phytosome 550 or 1100 mg (188 or 376 mg berberine)
DurationAcute crossover; sampling through 12 hours
EndpointsPlasma exposure and pharmacokinetics; Drug interaction measurements; Short-term tolerability

What the study showed, in plain terms

The phospholipid preparation increased measured berberine exposure. Its dose includes formulation ingredients and must be interpreted on an active-ingredient basis.

Key findings

  • The phospholipid preparation increased measured berberine exposure. Its dose includes formulation ingredients and must be interpreted on an active-ingredient basis.

What this study can and cannot tell us

Industry-employed authors and acute exposure endpoints; does not establish clinical superiority.

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